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Study of Interventional Pulmonologic Treatment of Malignant Central Airway Stricture

Prospective, Open, Multicenter Study of Interventional Pulmonologic Treatment of Malignant Central Airway Stricture

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02299830
Enrollment
200
Registered
2014-11-24
Start date
2014-12-31
Completion date
2017-12-31
Last updated
2014-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Airway Obstruction

Keywords

neoplasm, central airway, obstruction

Brief summary

The purpose of this study is to evaluate the efficacy and safety of four interventional pulmonology techniques for the treatment of malignant central airway stricture. The four techniques are: * cryotherapy * argon plasma coagulation * stent * snare

Interventions

PROCEDUREcryotherapy

use cryotherapy to delete soft neoplasm tissue in the airway

use argon plasma coagulation to delete hard neoplasm tissue in the airway

use stent placement to open the airway compressed by out neoplasm

PROCEDUREdeletion tumor tissue by snare

use snare to delete polypoid neoplasm tissue in the airway

Sponsors

Changhai Hospital
CollaboratorOTHER
The First Affiliated Hospital of Guangzhou Medical University
CollaboratorOTHER
Xinqiao Hospital of Chongqing
CollaboratorOTHER
China Meitan General Hospital
CollaboratorOTHER
Micro-Tech (Nanjing) Co., Ltd.
CollaboratorINDUSTRY
Tang-Du Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* malignant neoplasm caused central airway stenosis * the degree of stenosis is above 50% * estimated survival duration is longer than 3 months * received no treatment one month before * can understand the statement informed consent * agree to enroll in the study

Exclusion criteria

* older than 70 years or younger than 18 years * not malignant neoplasm caused central airway stenosis * not central airway stenosis * existence of lumina collapse or twisting * severe arrhythmia, myocardial ischemia or hypertensive crisis * coagulation disorders * existence of severe organ disfunction * allergic to anesthesia drugs * refuse to participate the study

Design outcomes

Primary

MeasureTime frame
percentage of the cases that got Ⅰand Ⅱlevel remissionthe next day after the treatment

Secondary

MeasureTime frame
the values of dyspnea indexthe next day after the treatment
Karnofsky Physical scalesthe next day after the treatment

Other

MeasureTime frame
adverse event during the treatmentfrom the beginning of the treatment to 48 hours after the treatment

Countries

China

Contacts

Primary ContactDeguang Mu, Ph.D
deguang@fmmu.edu.cn86-29-777825
Backup ContactYandong Nan, MD
nanyandong2008@163.com86-29-84717533

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026